Composition and uses for influencing hair growth

ABSTRACT

The invention describes a combination of at least one aromatase inhibitor selected from the group of chemical-synthetic aromatase inhibitors and aromatase inhibition exhibiting extracts of soya beans and rapeseed, respectively, and at least one plant extract that contains one or more active ingredient substance(s) extracted from the plant, which is(are) selected from the group of 5α reductase type I and/or type II inhibitors and androgen receptor blockers, said combination being contained for example in a composition and having special properties for influencing hair growth. Uses of this combination are also described.

The present invention relates to a composition that is particularlysuitable for influencing hair growth, as well as to uses relatedthereto.

For many decades the research of hormone-dependent hair growth has beendominated by androgens. To this day, the androgen-metabolism and theandrogen receptors are targets of both, the systemic pharmacologicalinfluencing of hair growth in the medicine and of the local, cosmeticattempts to control hair growth.

However, it has been known for a long time that also estrogens have asignificant influence on the hair follicles with respect to growth andcycle. Namely via binding to the local estrogen receptors.

Accordingly, it could be observed that an increase in local estradiollevels via local estradiol administration resulted in an increase inbody hair. An adverse observation could be made when administeringlocally estradiol to the skin of the head: Here, the increased estradiollevel and the increased local estradiol activity, respectively, led tohair loss. Basis of positively influencing the growth of head hair isthat each hair follicle constitutes a unique “microcosmos” having theability of complete self-regeneration. This is based on the interactionsof its epithelial and mesenchymal components. These interactions alsorelate to the local development and the interplay of the sex hormones.These mechanisms of course play an equal role for body hair, althoughpartially acting against each other. In addition to their regulatoryfunction within the hair follicle cycle, these factors likewise play animportant role within the hair pigmentation.

The key concept is therefore that in principle estrogens and androgenshave a direct hair growth modulation function and, in addition thereto,indirectly act by varying the expression of important hair growthmodulating factors. It is a basis of this concept that the two essentialenzymes for the genesis of the active sex hormones, aromatase for theconversion of testosterone to estradiol and 5α reductase (type I andtype II) for the conversion of testosterone to dihydrotestosterone, arestrongly expressed and active in the region of the hair follicles. Thesame is true for the expression of the estrogen receptors α and β and ofthe androgen receptors. This means that the skin not only has aprotective and regulatory function, but that the skin in addition is animportant endocrine organ.

In the past there have been proposals to use aromatase inhibitors ascosmetic means and for influencing the hair growth, as e.g. discussed inWO 96/08231 A.

In a series of documents, saw palmetto extracts (Serenoa repens) arementioned, predominantly in connection with pharmaceutic-therapeuticconcepts, see e.g. JP 2007 230888 A with regard to androgen independentcancer; US 2006 246153 A with regard to benign prostate hypertrophy(BPH); JP 2007 051129 A as a component of a composition for anantagonist of angiotensin II1 type receptor or as inhibitor of theangiotensin I converting enzyme; WO 03/030887 A for treatment of sexualdisorders and erectile dysfunctions, respectively; U.S. Pat. No.6,599,540 for prevention and/or treatment of prostate cancer; US 2002001633 A for treatment of inter alia BPH and prostate cancer; DE 10127897 for treatment of osteoporosis or related disorders; WO 01/39656 Afor treatment of symptoms of the lower urinary tract (LUTS) and of BPH;FR 2791255 with regard to anti-androgenic effect of cosmetic anddermo-pharmaceutic compositions; JP 2000 256204 A with regard to acomposition with increased prostatomegaly inhibiting effect; WO 99/21009A for preparation of suitable saw palmetto extracts; WO 97/03639 fortopical cosmetic skin applications; EP-A-0204877 as dermatological topiccomposition for the treatment of acne; respectively in combination withdifferent active ingredients as well as carriers. Besides, furtherdocuments deal with hair applications, see e.g. JP 2002 322050 A with acomposition of saw palmetto extracts with cystine (raw material ofhair), citric acid and theanine for activation of the hair root and forbringing about the hair growth via oral administration, US 2001 033849 Awith cosmetic compositions comprising fatty acids and anti-androgenestyrenes of saw palmetto extracts and/or Cucurbita seed (Cucurbitapepo), U.S. Pat. No. 6,019,976 with therapeutic formulations containingsaw palmetto extracts, vitamin B6, vitamin B3, zinc salt and L-argininefor treatment of male baldness via topical hair application, JP 11092340 A with a formulation of saw palmetto extracts and a specificamount of an oil-soluble component of Allium sativum L. for supportingthe blood stream and with a subsequent expected improvement of a hairrenewing effect, and, therefore, for the treatment or the prevention ofmale hair loss, JP 60 215608 A with a saw palmetto extract for a hairstrengthening preparation, WO 03/013561 A with pharmaceutical and/orcosmetic compositions containing extracts of saw palmetto and Vitisvinifera as effective components for treatment and prophylaxis of hairloss, of dandruffs and seborrhea, as well as WO 98/33472 with sawpalmetto extracts or components thereof for prevention and/or treatmentof androgenic hair loss and/or hirsutismus.

WO 91/02516 A relates to the use of a coleus extract for skinpigmentation, wherein supplementary substances such as xanthine,theophiline, tyrosine, chinine, skin irritant agents, 5α reductaseinhibitors and saw palmetto extracts can be used, however, said documentdiscloses—with regard to document EP-A-0 293 837 that deals withinfluencing of melanocytes of hair roots and therefore with thetreatment of the hair—that in particular with regard to the metabolismwide differences exist between melanocytes in hair follicles andmelanocytes in the skin.

Other documents deal with attempts of influencing and in particular ofinhibiting 5α reductase.

U.S. Pat. No. 7,238,375 B1 describes four complexes 1-4, whereincomplexes 1-3 should prevent hair loss and complex 4 should bring abouthair growth. A mixture of copper ions, palm extract (Serenoa repens),pygeum extract (Pygeum africanum), nettle extract (Urtica dioica), zinc,vitamin B6 and linolenic acid belongs to complex 2.

U.S. Pat. No. 7,105,573 B2 and US2007/0066661 A1 relate to furthersuggestions for treating hair loss and other diseases that are linked tohair follicles.

The article of W. CHEN et al., “Cutaneous Androgen Metabolism: BasicResearch and Clinical Perspectives”, J Invest Dermatol. Vol. 119, No. 5,November 2002, pp. 992-1007 describes the androgen metabolism of theskin in general; and R. HOFFMANN and R. HAPPLE, “Current understandingof androgenetic alopecia. Part I: Etiopathogenesis”, Eur J Dermatol. Vol10, No. 4, June 2000, pp. 319-327 give a general overview of the stateof knowledge in androgenic alopecia (AGA), wherein both cited articlesgive an impression of the complex circumstances of the anatomic regionsthat are relevant for skin and hair phenomena.

M. E. SAWAYA M. E., “Different Levels of 5α-Reductase Type I and II,Aromatase, and Androgen Receptor in Hair Follicles of Women and Men withAndrogenetic Alopecia”, J Invest Dermatol. Vol. 109, No. 3, September1997, pp. 296-300 report on differences in the occurrence of theandrogen receptor and of steroid-converting enzymes (5α reductase,aromatase) in man and woman and speculate that this could be responsiblefor the different clinical picture of AGA in man and woman. A list ofpossible active ingredients that can be assigned to respective plantscan be found at Dr. Duke's Phytochemical and Ethnobotanical Databases,URL:http://www.ars-grin.gov/duke.

As explained above, the influencing of the hair growth refers to ahighly complex system. This is reflected in a correspondingly highcomplexity of biochemical analyses and suggestions for influencing them.Despite a multitude of attempts the hitherto existing approaches havenot been able to develop a proper balance with regard to adifferentiated local influencing of the leading metabolites such asestrogens (in particular estradiol) and androgens (in particulardihydrotestosterone), depending on whether the hair growth or the hairremoval—and inhibiting of the re-growth of hair after epilation ordepilation, respectively—dependent on the treated skin region, i.e. onthe one hand skin of the head (scalp) and on the other hand skin of thebody including face (in particular beard area), and dependent on whetherwomen or men are affected. A satisfying differentiated solution forspecifically influencing in man as well as in woman has not yet beenfound. In particular, a depigmentation of hair represents anunpredictable problem in influencing the hair growth.

Therefore, it is an object of the present invention to provide animproved composition for influencing the hair growth and the hairpigmentation.

According to the invention it has been surprisingly found that if atleast one aromatase inhibitor, selected from the group ofchemical-synthetic aromatase inhibitors and aromatase inhibitionexhibiting extracts of soya beans and rapeseed, respectively, (component(i)), is combined with at least one plant extract (component (ii)) thatcontains one or more active ingredient substance(s) extracted from theplant, which is(are) selected from the group consisting of 5α reductasetype I and/or type II inhibitors and androgen receptor blockers, notonly a targeted controllable influencing of the hair growth is reached,but at the same time also the hair pigmentation is controlled. In thisway, either a hair depigmentation in woman, or, on the other hand,protection against hair depigmentation in man, can be achieved.

The novel combination according to the invention is characterized by anadvantageous targeted influenceability of the hair growth, dependent onwhether hair growth or hair removal and inhibition of new growth of hairdependent on the region of the body (scalp/skin of the head orbody/face/beard area), respectively, and dependent on whether women ormen are affected. Thereby, it namely has been surprisingly found outthat the combination according to the invention allows for a targetedand differentiated influencing of the metabolites that are essential tohair growth such as estradiol and dihydrotestosterone, based on thelocal circumstances—i.e. specific for bringing about hair growth on theskin of the head/scalp in man or woman and for hair removal andinhibition of new growth of hair after epilation or depilation on thebody (including beard area), respectively, in man or woman—combined withthe possibility of a favourable influencing of the hair pigmentation andin particular re-pigmentation of hair, and, therefore, a return to thenatural hair color.

For the differentiated combined effect according to the invention it isimportant that an effective aromatase inhibition is effected fast andefficiently, which is why component (i) is on the one hand selected fromthe group of chemical-synthetic aromatase inhibitors and/or on the otherhand from aromatase inhibition exhibiting extracts of soya beans and/orrapeseed, respectively.

As a chemical-synthetic aromatase inhibitor that can be used in thecomposition according to the invention a substance that is known to havethis function can be used, cf. e. g. A. M. H. Brodie in: “J. SteoridBiochem. Molec. Biol.”, Vol. 49, No. 4-6, pp. 281-287 (1994), as well asP. E. Goss and K. M. E. H. Gwyn in: “Journal of Clinical Oncology”, Vol.12, No. 11, pp. 2460-2470 (1994), and for detection of the aromataseinhibition see e.g. A. M. H. Brodie et al. in: “J. Steroid Biochem.Molec. Biol.”, Vol. 7, pp. 787-793 (1976), and D. A. Marsh et al. in:“J. Med. Chem.”, Vol. 28, pp. 788-795 (1985). Suitable aromataseinhibitors can for instance be selected from the following group ofcompounds:

Steroidale Aromatase Inhibitors:

4-hydroxyandrost-4-ene-3,17-dione (formestan and lentaron),

6-methyleneandrostra-1,4-diene-3,17-dione (exemestane),

10-(2-propynyl)estr-4-ene-3,17-dione (MDL 18962)

7-alpha substituted androstendione-derivatives

1,4,6-androstatriene-3,17-dione (ATD)

10-oxirane- and 10-thiirane-substituted androgens

10-propargylestr-4-ene-3,17-dione

10-propargylestr-4-ene-3,17-propionate-10-(2-propynyl)-derivative

13-retro-antiprogestine

14-alpha-hydroxy-4-androstene-3,6,17-trione (14-alpha-OHAT)

16- or 19-substituted androst-4-enes

19-(cyclopropylamino)-androst-4-ene-3,17-dione

19-(ethyldithio)-androst-4-ene-3,17-dione

19-oxiranyl- and 19-thiiranyl-steroids

19-thiomethyl- and 19-azido-androstenedione

1-methyl-androsta-1,4-diene-3,17-dione (atamestane)

2,2-dimethyl-4-hydroxy-4-androstene-3,17-dione

3-alpha-methoxyandrost-4-ene-6,17-dione

3-beta-hydroxyandrost-4-ene-6-one-derivative

3-deoxyandrogen-19-oxygenatederivatives of 3-oxo-17beta-carboxamido-steroids

4-(phenylthio)-4-androstene-3,17-dione

4-(thio-substituted)-4-androstene-3,17-dione

4-acetoxy-4-androstene-3,17-dione

4-aminoandrostenedione

4-androsten-3,6,17-trione

4-hydroxyandrostenedione (4-OHA)

4-methoxy-4-androstene-3,17-dione

4-oxygenated androst-5-ene-17-one and their 7-oxo-derivatives

4-thiosubstituted derivatives of 4-androstene-3,17-dione

4-thiosubstituated-4-androstene-3,17-dione-derivatives

5-alpha-dihydronorethindrone (a metabolite of norethindrone)

5-alpha-reduced C19-steroids

5-alpha-androstan-17-ones with or without a carbonyl functionality atC-3 and/or C-6

6-alpha-7-alpha-cyclopropanederivatives of androst-4-ene

6-alpha-fluorotestosterone

6-beta-propynyl-substituted steroids

6,7-aziridinylsteroide and related compounds

6-alkylanalogs of delta 1,4,6-androgens

6-alkyl- and 6-arylandrost-4-ene-3,17-dione

6-alkylandrost-4-ene-3,17-dions of 7 alpha- and7-beta-arylaliphatic-substituted androst-4-ene-3,17-diones

6-alkylandrosta-4,6-diene-3,17-dione and their 1,4,6-triene-analogs

6-alkyl-substituted androgens

6-phenylaliphatic-substituted C19-steroids with 1,4-diene-, 4,6-diene-or 1,4,6-triene-structure

6-bromoandrostenedione

6-hydroximinoandrostenedione

6-methyleneandrosta-1,4-diene-3,17-dione (FCE 24304)

6-methyleneandrosta-1,4-diene-3,17-dione (FCE 24304)

6-phenylaliphatic-substituted androst-4-ene-3,17-diones

6-substituted androst-4-ene-analogs

7-alpha-(4′-amino)phenylthio-4-androstene-3,17-dione

7-alpha-substituted androsta-1,4-diene-3,17-diones

7-alpha-substituted androstenediones

7-alpha-(4′-amino)phenylthio-4-androstene-3,17-dione

7-alpha-arylaliphatic androsta-1,4-diene-3,17-diones

7-alpha-substituted androstenediones

7-substituted 4,6-androstadiene-3,17-diones

7-substituted steroids

Androst-4-ene-3,6-dione derivatives

Androst-5-ene-7,17-dione 19-nor- and 5-beta-6-beta-epoxy-derivatives

A-or B-ring-substituted derivatives of androst-4-ene-3,6,17-trione

A-ring bridged steroids

Bromoacetoxy-4-androstene-3-one

delta-1,4,6-androgens

delta-4,6-androgens

epimeric 6-hydroperoxyandrostenediones

Estr-4-ene-3,17-dione (MDL 18 962),

Estr-4-ene-3,6,17-trione

Flavonoids

RU486

Non-steroidal Aromatase Inhibitors:

6-[(4-chlorophenyl)(1H-1,2,4-triazole-1-yl)-methyl]-1-methyl-1H-benzotriazole(vorazol),

2,2′-[5-(1H-1,2,4-triazole-1-ylmethyl)-1,3-phenylene]bis(2-methylproprionitrile) (arimidex),

4-[1-(cyanophenyl)-1-(1,2,4-triazolyl)methyl]benzonitrile (letrozole),

{4-(5,6,7,8-tetrahydro-imidazo-[1,5a]-pyridine-5-yl) benzonitrilemonohydrochlorid (fadrozole)

Pyridoglutethimide (rogletimide)

Aminogluthetimide

1,2-imidazolylmethylcyclopentanole-derivatives

1-[(benzofurane-2-yl)phenylmethyl]-triazoles and -tetrazoles

1-[benzofurane-2-yl)-phenylmethyl]-imidazoles (substituted)

1-(benzofurane-2-ylmethyl)imidazole ofN,N-disubstituted-5-aminopyrimidine-derivatives

1-imidazolyl(alkyl)-substituted di- and tetrahydrochinolines

1-pentyl-3-(4-aminophenyl)pyrrolidine-2,5-dione

1-phenyl-3-azabicyclo[3.1.0]hexane-2,4-dione

1-phenyl-3-azabicyclo[3.1.0]hexane-2,4-dione and analogs

3-alkylated 3-(4-aminophenyl)piperidine-2,6-diones

3-cycloalkyl-substituted 3-(4-aminophenyl)piperidine-2,6-diones

3-ethyl-3-(4-pyridyl)piperidine-2,6- and 5-alkyl derivatives

3-ethyl-3-(4-pyridyl)piperidine-2,6-dione-analogs

4-amino-4H-1,2,4-triazole-derivatives

4-cyclohexylaniline

Aminoglutethimide

Benzimidazole- and imidazole-compounds

Delta-1,4-bisnorcholadiene acid

Delta-1-testolactone

Imidazole derivatives of pyrrolidonic and piperidonicimidazolyl-1,3,5-triazines

MR 20492 and MR 20494 (two indolizinone derivatives)

Pyridyl-substituted indanones, indanes and tetralines

Triazine derivative SEF19

Substituted pyridines

Testololactone

Further Aromatase Inhibitors:

8-bromo-cyclic adenosinemonophosphate

FR901537

Hexamethylmelamine derivative (SAE9)

Letrozole (CGS 20267)

Mefloquine

MPV-2213ad

N-n-octanoylnornicotine and further nornicotine derivates

Org 33201

R 76713 and R 76713

Sesquiterpenelactone

SH 489

TAN-931

Thyroidhormons

Tobakalkaloid derivatives

YM511

As to the labelling of said substances as well as to their availability,see e.g. “Rote Liste”, Editio Cantor Verlag, Aulendorf (DE), 2003. As analternative to the use of the aforementioned compounds, or as additionalcomponent, it is preferred to employ an extract of soya beans (Glycinesoya), and even better a rapeseed extract (Brassica campestris; engl.:rapeseed), with regard to an effectiveness in aromatase inhibition onthe one hand, and a well-tolerated treatment of skin regions for apreferred local and topic application of the composition on the otherhand. The respective extracts of soya beans and/or of rapeseed can beobtained for the inventive use as aromoatase inhibitor component in sucha way that fractions are obtained respectively by suitable extractionand, if applicable, selective separation and isolation of thosecomponents of soya beans and/or rapeseed and rapeseed oil exhibitingaromatase inhibition function. Extracts of soya beans and, even better,extracts of rapeseed, can in addition advantageously bring forth a 5αreductase inhibition property, which allows for an even moreadvantageous mode of action, as described below. The selective isolationof extract fractions having aromatase and/or 5α reductase inhibitingfunction can be verified by appropriate testing of the fractions for therespective inhibitory effect and can be collected accordingly, whereinin each case known specific inhibition assays can be used.

The inventive combination effect is achieved by further using at leastone plant extract that contains an active ingredient substance extractedfrom a plant selected from the group consisting of 5α reductase type Iand/or type II inhibitors and androgen receptor blockers. Theapplication of said plant extract shows clear advantages for theinventive purpose compared to the application of singlechemical-synthetic 5α reductase inhibitors and is preferred, e.g.because in this case, steroidal phytosteroles and/or flavanoids areobtained as particularly favorable inventive active ingredients and/orbecause, in this case, regularly a total mixture of structurally and, asthe case may be, functionally, different active ingredients areobtained. Consequently, according to the invention, such a plant extractis particularly preferred that contains multiple active ingredientsubstances extracted from the plant, i.e. a mixture of activeingredients that are selected from the group consisting of 5α reductasetype I and/or type II inhibitors and androgen receptor blockers.

Plant extracts that can be used within the scope of the presentinvention that have an effect in inhibiting the 5α reductase type Iand/or type II, preferably both, type I and type II form, areparticularly preferred extracts from the following plants, respectivelyalone or in combination: Saw palmetto extract (Serenoa repens); Taxuschinensis (Pilg.) Rehd., Canarium pimela Koenig, Beteropanax fragrans(Roxb.) Seem., Andrographis paniculata (Burm. f.) Nees, Acer palmatum,Zosteraceae, zostera sp., Yacon (a natural plant originating from Peru,belonging to the genus of Asteraceae, botanical name: Polyrmioasonchifolia), sesame, gooseberry (genus Phyllanthus of the familyEuphorbiaceace, botan. name Phyllanthus emblica), Striga asiatica (L.)O. Kuntze, Butea monosperma (Lam.) Taub., Alangium chinense (Lour.)Harms, Alternanthera sessilis (L.) R. Br., Procryis wightiana wall exWedd, Desmodium triflorum (L.) DC., Stephania japonica Miers.,Polypodium vulgare, Quercus-plant (genus), Psidium guajava L, Plumbagozeylanicum L., Cyperus rotundus L., Ricinus communis L., Embelia ribesBurm. f., Jangkang, Daun trawas, Cuachalalat (originates from theAcapulco region in the South of Mexico), Piper methysticum (genus Piper,family Piperaceae), Impatiens balsamina L., Thuja orientalis (family ofthe cypress), plants of the genus Coriandrum as e.g. Corlandrum sativumL., Cassia auriculata (in particular bark), Quercus pedunculata (inparticular fruits), Rumex cyprius, Sumilax zeylanica, Phyllanthusnuriri, Woodfordia fruticosa, Lagerstroemia speciosa, Cymbopogon nardus,Glycyrrhiza glabra or Rheum, Belamcanda chinensis DC. (familyIridaceae), Rosa rugosa Thunb, Saxifraga stolonifera Meerburg, Garciniamangostana L., Nephelium lappaceum L., Pyrola japonica Klenza,Trichosanthes cucumeroides Maxim, Kadsura japonia Dunal, Cuscutaaustralis R. Br., Cuscuta japonica Choisy, Euchresta japonica Benth.,Lilium makinoi Koidzumi, balbatimone, Rosaceae such as peach, Rosarugasa, Rosa odorata, Rosa odorata, R. coptophyllus, Rosa centifolia,Sanguisorba officinalis L. or Pseudocydonia siensis, Leguminosae,Polygoni multiflori radix, Chaenomelis fructus, Zanthoxylic fructus,Thujae orientalis, Landium domesticum Jack var. Duku (Duku) or Landiurndomesticum Jack var. Langsat (Langsat) of the family Meliaceae, Uncariagambir, fennel, polygala, liquorice, pharbitis, plantane, clove,arecanuts, kolophonium, Stachys betonica, Geranium herb, Pounellaespical, Bupleurum elatum, Artenisiae capillaris Flos, Rosae fructus,Coicis semen, Nepetae herba, Dichroa, Valeriana officinalis.

Plant extracts that can be used within the scope of the presentinvention that have an effect in blocking the androgen receptor(anti-androgen) are preferred, in particular the following extracts,respectively alone or in combination: Chromolaena odoratum (L.) K. R.,coconut oil, Cuban king palm (Roystonea regia), Pygeum africanum,Serenoa repens, Cucurbita pepo, Albizia lebbeck (L.) Benth (from bark),Roystonea regia (from fruits), Ruta graveolens L, Azadirachta indica A.Juss (from leaves), Momordica charantia (from seeds), Ganoderma lucidum,Echinacea purpurea, Belamcanda chinensis, Citrus aurantium, Echinaceapurpurea, Silybum marianum (milk thistle), Crotalaria juncea Linn,Pygeum africanum, pumpkin seed oil, crimson clover (in particular,flavanoid-rich components; Trifoleum pratense) pine (Pinus), spruce(Picea), rye (flower pollen extract), soya, Pygeum africanum, Hypoxisrooperi (root), stinging nettle (Urtica dioica), Cordia multispicata(Triterpenoid extract) from Brazil, Myricae cortex (Myrica rubra Sieb.et Zucc., Myricaceae, from bark), Pygeum africanum (Tadenan; barkextract from the African plum), Azadirachta indica, Sophora flavescens,Hibiscus rosa sinesis, Dalbergia cochinchinensis, Fructus psoraleae,Striga orobanchioides, and Vitex negundo (from seed).

Extracts of fruits of the saw palmetto (Serona serrulata fruit extract)(in particular the ethanol extract), of pumpkin seeds, stinging nettle,Taxus chinensis (Pilg.) Rehd., Canarium pimela Koenig, Heteropanaxfragrans (Roxb.) Seem. and Andrographis paniculata (Burm.f.) Nees areparticularly preferred used as they inhibit the 5α reductase (type I andtype II) and at the same time allow for a blockade of androgenreceptors.

In general, the extract can be obtained from the whole plant or a partthereof, e.g. from leaves, stems or branches, from the bark, flowers,fruits, roots or the like. Preferably, prior to the extraction, theplant source is grinded, crushed or pulverized. Further optionalprocessing steps are heating, refluxing, filtration, concentration,spray drying, freeze-drying. Preferably, a specific isolation stepseparating the extracted sample e.g. by using appropriatechromatographic methods, and isolating the respective fractions with thedesired effect and, as the case may be, further purifying, is added. Bydoing so, for instance the isolation of the target can take place bydetermining and verification of the respective desired activity, and/orby testing for a substantial content of flavanoids and/or preferably ofphytosterols, in particular of beta-sitosterol, stigmasterol andcampesterol. Particularly preferred, the plant extract of component (ii)represents an extract being rich in phytosterolenes and/or flavanoids,i.e. the proportion of phytosterolenes and/or flavanoids based on thetotal plant extract of component (ii) is e.g. at least 50% by weight,further preferred at least 75% by weight and in particular at least 90%by weight.

In order to predominantly isolate the preferred steroidal activeingredients from the mentioned plants, they are preferably extractedwith organic solvents, e.g. with methanol, ethanol, hexanol, glycol,such as ethylene glycol or 1,3-butyleneglycol, acetone, hexane, benzene,toluene, chloroform. A particularly preferred extracting agent isethanol.

According to the invention, it is particularly preferred if eithercomponent (i) or component (ii), even better at the same time bothcomponents, inhibit(s) the type I or the type II 5α reductase and,further preferred, both isoforms, in order to allow for amultifunctional mechanism of action without having to admix furtheractive substances and therefore potentially generating unpleasantside-effects. Hereby, an optimized combination of active substances thatis in particular characterized by a beneficial influencing of thepositive hair growth of the head hair with the possibility of are-pigmentation of the hair by an otherwise strong pushing back of thehair growth of the body hair (as well as for the so called “facial hairon the chin and upper lip of women” (in German: “Damenbart”) isobtained, provided that only the aromatase inhibitor—in the form of oneor more of the chemical substances mentioned above and/or in the form ofa soya bean extract or of a rapeseed extract—as active principle iscombined with the plant extract of component (ii) and in particular witha saw palmetto extract, without adding further pharmacological activesubstances, but only suitable carriers, excipients or additives,depending on the desired formulation. This is in particular the casewhen an aromatase inhibitor is used that inhibits the aromatase bycovalent binding to the aromatase, in particular when using4-hydroxy-androstenedione, 4-acetoxy-andostenedione or a4-ester-derivative thereof, wherein the ester group can contain commonalkyl groups such as methyl-, acetyl-, n- or iso-propyl-, n-, sec- ort-butyl ester.

It is assumed that when using component (i) having aromatase inhibition,preferably selected from 4-hydroxy-androstenedione,4-acetoxy-andostenedione, a 4-carboxylic acid ester derivative thereof,soya bean extract and rapeseed extract, each with aromatase inhibitioneffect, in combination with the plant extract of component (ii), amulti-modal mechanism of action is carried out, namely apart from theinhibition of the aromatase at the same time an inhibition of the 5αreductase (type I and type II) and, in addition thereto, a blockage ofthe androgen receptors, without the requirement of further, as the casemay be unpleasant, additives of active ingredients.

The amounts of the above mentioned active substance components—i.e. eacharomatase inhibitor, saw palmetto extract and, as the case may be,additional 5α reductase inhibitor—are for example, each independently,ranges of from 0.0001 to 50% by weight, preferably of from 0.001 to 20%by weight, further preferred of from 0.01 to 10% by weight, and inparticular of from 0.1 to 5% by weight, respectively based on the totalcomposition.

In addition to the above-mentioned active ingredients, the compositionaccording to the invention can contain conventional carriers, excipientsor additives. In particular, such additives are possible that aresuitable for topical routes of administration. Additives include forinstance vegetable oils such as almond oil, olive oil, peach kernel oil,peanut oil, castor oil and the like, plant extracts, essential oils,vitamin oils, lipids and lipid-like substances, lipoids, phosphotides,hydrocarbons such as paraffins, petrolatum, lanolin, waxes and the like,detergents, further skin active agents such as lecithine, wool fat,carotene and the like, skin nutrients, perfumes, cosmetic substances,alcohols, water and water mixtures, glycerol, glycol, urea, talc,preservatives, sunscreens, colorants such as titanium white and zincwhite, and anti-oxidants or the like, as well as mixtures of saidsubstances, however without being restricted thereto. In general, waterserves as basic substance, so that—conventionally by the addition ofemulsifiers such as fatty alcohol sulphate, alkali soaps, lecithines,triethanolamine and the like—an O/W- or W/O-emulsion is obtained.Commercially available, conventional skin care products are alsoapplicable as base mixture in addition to the active substances.

Suitable types of formulations for the composition according to theinvention are for instance an ointment, a cream, a gel, an emulsion, alotion, a spray, a powder, an oil or the like. Preferably, thecomposition according to the invention is however free of harmful,undesired or even toxic additives, in particular is free of metallicadditives such as copper.

In the following, the invention is discussed in more detail by means ofthe following examples that are however not to be understood in alimiting way. Data in percent mean percent by weight of the respectivecomposition.

EXAMPLES 1-8

In the following Examples 1-8, the given ingredients (active ingredientsand mixtures of active ingredients, respectively) for preparation oftinctures for influencing the hair growth were respectively applied tomen and women.

Hair Growth Head Men Example 1

AQUA 14.24%, DIMETHYL ISOSORBIDE 10%, SERENOA SERRULATA FRUIT EXTRACT0.99%, 4-HYDROXY-ANDROSTENEDIONE 0.6%, URTICA DIOICA (NETTLE) EXTRACT1%, TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID0.05%, and rest ALCOHOL DENAT. (70%).

Example 2

AQUA 14.24%, DIMETHYL ISOSORBIDE 10%, SERENOA SERRULATA FRUIT EXTRACT0.99%, ACETOXYANDROSTENEDIONE 0.6%, URTICA DIOICA (NETTLE) EXTRACT 1%,TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID0.05%, and rest ALCOHOL DENAT. (70%).

Example 3

AQUA 14.33%, DIMETHYL ISOSORBIDE 10%, SERENOA SERRULATA FRUIT EXTRACT1%, GLYCINE SOYA (SOYBEAN) STEROLS 0.5%, URTICA DIOICA (NETTLE) EXTRACT1%, TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID0.05%, and rest ALCOHOL DENAT. (70%).

Example 4

AQUA 14.33%, DIMETHYL ISOSORBIDE 10%, SERENOA SERRULATA FRUIT EXTRACT1%, BRASSICA CAMPESTRIS (RAPESEED) STEROLS 0.5%, URTICA DIOICA (NETTLE)EXTRACT 1%, TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYLPALMITATE 0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSEEXTRACT 0.2%, MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYLDISUCCINATE 0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%,NIACINAMIDE 0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEAEUROPAEA (OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%,PEG-40 HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTICACID 0.05%, and rest ALCOHOL DENAT. (70%).

Hair Growth Head Women Example 5

AQUA 14.33%, DIMETHYL ISOSORBIDE 10%, 4-HYDROXY-ANDROSTENEDIONE 0.7%,SERENOA SERRULATA FRUIT EXTRACT 0.8%, URTICA DIOICA (NETTLE) EXTRACT 1%,TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID 0.05,and rest ALCOHOL DENAT. (70%).

Example 6

AQUA 14.33%, DIMETHYL ISOSORBIDE 19%, ACETOXYANDROSTENEDIONE 0.7%,SERENOA SERRULATA FRUIT EXTRACT 0.8%, URTICA DIOICA (NETTLE) EXTRACT 1%,TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID0.05%, and rest ALCOHOL DENAT. (70%).

Example 7

AQUA 14.23%, DIMETHYL ISOSORBIDE 10%, GLYCINE SOYA (SOYBEAN) STEROLS 1%,SERENOA SERRULATA FRUIT EXTRACT 0.6%, URTICA DIOICA (NETTLE) EXTRACT 1%,TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYL PALMITATE0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSE EXTRACT 0.2%,MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYL DISUCCINATE0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%, NIACINAMIDE0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEA EUROPAEA(OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%, PEG-40HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTIC ACID0.05%, and rest ALCOHOL DENAT. (70%).

Example 8

AQUA 14.23%, DIMETHYL ISOSORBIDE 10%, BRASSICA CAMPESTRIS (RAPESEED)STEROLS 1%, SERENOA SERRULATA FRUIT EXTRACT 0.6%, URTICA DIOICA (NETTLE)EXTRACT 1%, TUSSILAGO FARFARA (COLTSFOOT) LEAF EXTRACT 0.2%, RETINYLPALMITATE 0.05%, TOCOPHEROL 0.02%, ZINC PCA 0.2%, EQUISETUM ARVENSEEXTRACT 0.2%, MALVA SYLVESTRIS (MALLOW) EXTRACT 0.4%, DISODIUM CYSTINYLDISUCCINATE 0.2%, PIROCTONE OLAMINE 0.2%, TRIDECYL SALICYLATE 0.2%,NIACINAMIDE 0.1%, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT 0.4%, OLEAEUROPAEA (OLIVE) OIL UNSAPONIFIABLES 0.4%, BIOTIN 0.2%, UREA 0.25%,PEG-40 HYDROGENATED CASTOR OIL 0.05%, PROPYLENE GLYCOL 0.05%, LACTICACID 0.05%, and rest ALCOHOL DENAT. (70%).

EXAMPLES 9-14

In the following Examples 9-14, said ingredients for preparation ofcreams for influencing the re-growth of hair and the removal of hair(face and body) were used.

Hair Removal Body Example 9

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4%,OCTYLDODECANOL 3.9%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP CO POLYMER 0.85%, SERENOA SERRULATA FRUITEXTRACT 0.9%, BRASSICA CAMPESTRIS (RAPESEED) STEROLS 0.5%, GLYCINE SOYA(SOYBEAN) STEROLS 0.5%, TOCOPHERYL ACETATE 0.9%, TOCOPHEROL 0.0175%,CAPRYLOYL GLYCINE 0.1%, TRIBEHENIN 0.9%, GLYCERIN 0.9552%, XYLITOL 0.9%,SORBITOL 0.9%, PALMATINE 0.0024%, COCO-GLUCOSIDE 0.052%,ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE 0.09%,POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYL PALMITATE0.0175%, AMMONIA 0.0175, PHENOXYETHANOL 0.8%, XANTHAN GUM 0.1%, and restAQUA (66.7423%).

Example 10

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4%,OCTYLDODECANOL 3.9%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 0.85%, SERENOA SERRULATA FRUITEXTRACT 0.9%, ACETOXYANDROSTENEDIONE 0.5%, TOCOPHERYL ACETATE 0.9%,TOCOPHEROL 0.0175%, CAPRYLOYL GLYCINE 0.1%, TRIBEHENIN 0.9%, GLYCERIN0.9552%, XYLITOL 0.9%, SORBITOL 0.9%, PALMATINE 0.024%, COCO-GLUCOSIDE0.052%, ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE0.09%, POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYLPALMITATE 0.0175%, AMMONIA 0.0175%, PHENOXYETHANOL 0.8%, XANTHAN GUM0.1%, and rest AQUA (67.2423%).

Example 11

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4%,OCTYLDODECANOL 3.9%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 0.85%, SERENOA SERRULATA FRUITEXTRACT 0.9%, 4 -HYDROXY-ANDROSTENEDIONE 0.5%, TOCOPHERYL ACETATE 0.9%,TOCOPHEROL 0.0175%, CAPRYLOYL GLYCINE 0.1%, TRIBEHENIN 0.9%, GLYCERIN0.9552, XYLITOL 0.9%, SORBITOL 0.9%, PALMATINE 0.024%, COCO-GLUCOSIDE0.052%, ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE0.09%, POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYLPALMITATE 0.0175%, AMMONIA 0.0175, PHENOXYETHANOL 0.8%, XANTHAN GUM0.1%, and rest AQUA (67.2423%).

Hair Removal Face Example 12

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4.5%,OCTYLDODECANOL 4.4%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, BRASSICA CAMPESTRIS(RAPESEED) STEROLS 0.5%, GLYCINE SOYA (SOYBEAN) STEROLS 0.48%, SERENOASERRULATA FRUIT EXTRACT 0.9%, CAPRYLOYL GLYCINE 0.1%, TRIBEHENIN 0.9%,GLYCERIN 0.9552%, XYLITOL 0.9%, SORBITOL 0.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 1.25%, PALMATINE 0.024%,COCO-GLUCOSIDE 0.052%, TOCOPHERYL ACETATE 0.9%, TOCOPHEROL 0.0175%,ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE 0.09%,POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYL PALMITATE0.0175%, AMMONIA 0.0175%, PHENOXYETHANOL 0.8%, XANTHAN GUM 0.1%, andrest AQUA (65.3407%).

Example 13

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4.5%,OCTYLDODECANOL 4.4%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, ACETOXYANDROSTENEDIONE0.68, SERENOA SERRULATA FRUIT EXTRACT 0.9%, CAPRYLOYL GLYCINE 0.1%,TRIBEHENIN 0.9%, GLYCERIN 0.9552%, XYLITOL 0.9%, SORBITOL 0.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP CO POLYMER 1.25%, PALMATINE 0.024%,COCO-GLUCOSIDE 0.52%, TOCOPHERYL ACETATE 0.9%, TOCOPHEROL 0.0175%,ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE 0.09%,POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYL PALMITATE0.0175%, AMMONIA 0.0175%, PHENOXYETHANOL 0.8%, XANTHAN GUM 0.1%, andrest AQUA (65.6407%).

Example 14

DIMETHYL ISOSORBIDE 6%, PERSEA GRATISSIMA (AVOCADO) OIL 4.5%,OCTYLDODECANOL 4.4%, TRIDECYL SALICYLATE 2%, C12-13 ALKYL LACTATE 2%,CETEARYL ISONONANOATE 2%, CAPRYLIC/CAPRIC TRIGLYCERIDE 1.9476%,POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE 1.9%, 4-HYDROXY-ANDROSTENEDIONE0.68%, SERENOA SERRULATA FRUIT EXTRACT 0.9%, CAPRYLOYL GLYCINE 0.1%,TRIBEHENIN 0.9%, GLYCERIN 0.9552%, XYLITOL 0.9%, SORBITOL 0.9%, AMMONIUMACRYLOYLDIMETHYLTAURATE/VP CO POLYMER 1.25%, PALMATINE 0.024%,COCO-GLUCOSIDE 0.052%, TOCOPHERYL ACETATE 0.9%, TOCOPHEROL 0.0175%,ETHYLHEXYLGLYCERIN 0.3%, LACTIC ACID 0.12%, SORBITAN LAURATE 0.09%,POLOXAMER 407 0.5%, NYLON-12 0.06%, LECITHIN 0.028%, ASCORBYL PALMITATE0.0175%, AMMONIA 0.0175%, PHENOXYETHANOL 0.8%, XANTHAN GUM 0.1%, andrest AQUA (65.6407%).

The following application Examples 1 and 2 illustrate the resultsobtained with representatively selected compositions of preparationExamples (1-14) in cases with problems of hair growth and with excesshairiness on body and face, respectively.

Application Examples 1 and 2 Application Example 1: Influence on theHead Hair in Women and Men with Genetic Alopecia

In 10 women aged between 40 and 60 years and in 12 men aged between 34and 64 with severe genetic alopecia lotio preparations with thefollowing combinations of active ingredients were applied:

In women: A lotion having the composition according to Example 6 (n=4)and according to Example 5 (n=6), respectively.

In men: A lotion having the composition according to Example 2 (n=12).

Results:

Already after 3 months, all men and women exhibited both a positiveinfluence on the hair growth (amount of hair) and an increase in thethickness of the hair. In addition to an extremely remarkable increasein hair growth (amount of hair), after 6 months a considerable increasein the thickness of the hair appeared. Surprisingly, nearly all women(n=9) and nearly all men (n=10) exhibited a re-pigmentation of the hairand, therefore, a return to the original hair color.

Application Example 2: Excessive Hair Growth on the Legs (n=35) andSo-Called “Facial Hair on the Chin and Upper Lip of Women” (in German:“Damenbart”) (n=6) in Women Application to the Hair Growth on the Legsin Women

For 6 months, women exhibiting a strong hair growth on the legs (n=35)have been given a cream having the composition according to Example 10(N=15) or Example 11 (n=20).

Results:

The examination covered 180 days with examination time points in 30-dayintervals. The results were surprising. A reduction of the amount andthickness of hair could be detected already after 30 days. After 180days, the amount of hair per examination area was reduced by 89%,whereas in nearly 70% of the remaining hair a complete depigmentationoccurred, and in more than 95% of the women the remaining hairsubstantially decreased in thickness, thus becoming very fine. Theresults were identical for both cream preparations, thereby both showingthe same biological effectiveness.

Same effects could be detected in 6 women having so-called “facial hairon the chin and upper lip of women” by the application of a cream havingthe composition according to Example 13:

It is postulated that the selected combination of active substancesresults in a suppression of both the local estradiol and the localdihydrotestosterone generation, and, moreover, the possible effect ofthe circulating dihydrotestosterone in the hair papilla is blocked viablocking of the androgen receptors, for example based on the effects ofthe saw palmetto extract.

1.-19. (canceled)
 20. A method for treating a person in need thereof forreducing hair growth of body hair and/or facial hair, the methodconsisting essentially of topically applying to said person an effectiveamount of a composition consisting essentially of: (i) at least onearomatase inhibitor, selected from the group consisting of4-acetoxy-androstenedione, 4-hydroxy-androstenedione, aromataseinhibition exhibiting extracts of rapeseed, and aromatase inhibitionexhibiting extract of soybean, (ii) at least one plant extract whereinthe plant extract consists essentially of a mixture of 5α reductase typeI inhibitors, 5α reductase type II inhibitors, androgen receptorblockers, phytosterols and flavonoids, wherein the plant extract is atleast 90% by weight phytosterols and/or flavonoids based on the totalplant extract, and wherein the at least one plant extract is an extractselected from the group consisting of saw palmetto (Serenoa serrulatafruit extract), pumpkin seeds, stinging nettle, Taxus chinensis (Pilg.)Rehd., Canarium pimela Koenig, Heteropanax fragrans (Roxb.) Seem. andAndrographis paniculata (Burm. F.) Nees; and (iii) suitable carriersand/or excipients and/or additives, wherein said composition isformulated as a cream, a gel, an ointment or an emulsion.
 21. The methodaccording to claim 20, wherein component (i) inhibits 5α reductase. 22.The method according to claim 20, wherein component (ii) is an extractof saw palmetto (Serenoa serrulata fruit extract).
 23. The methodaccording to claim 20, wherein component (i) is a combination of anextract of soya beans and an extract of rapeseed, and component (ii) isan extract of saw palmetto (Serenoa serrulata fruit extract).
 24. Themethod according to claim 20, wherein component (i) is selected from thegroup consisting of 4-acetoxy-androstenedione and4-hydroxy-androstenedione, and component (ii) is an extract of sawpalmetto (Serenoa serrulata fruit extract).
 25. The method according toclaim 20, wherein the saw palmetto extract is an ethanol extract of sawpalmetto fruits.
 26. The method of claim 20, wherein the method is amethod for treating a person in need thereof for reducing hair growth onthe legs and/or facial hair on the chin and upper lip.
 27. The method ofclaim 20, wherein the person in need thereof is a woman.
 28. A methodfor treating a person in need thereof for reducing hair growth of bodyhair and/or facial hair, the method consisting essentially of topicallyapplying to said person an effective amount of a composition consistingessentially of: (i) at least one aromatase inhibitor, selected from thegroup consisting of 4-acetoxy-androstenedione,4-hydroxy-androstenedione, aromatase inhibition exhibiting extracts ofrapeseed, and aromatase inhibition exhibiting extract of soybean, (ii)at least one plant extract wherein the plant extract consistsessentially of a mixture of 5α reductase type I inhibitors, 5α reductasetype II inhibitors androgen receptor blockers, phytosterols andflavonoids, wherein the plant extract is at least 90% by weightphytosterols and/or flavonoids based on the total plant extract, andwherein the at least one plant extract is an extract of saw palmetto(Serenoa serrulata fruit extract); and (iii) suitable carriers and/orexcipients and/or additives, wherein said composition is formulated as acream, a gel, an ointment or an emulsion.
 29. The method according toclaim 28, wherein the at least one aromatase inhibitor inhibits 5αreductase.
 30. The method according to claim 28, wherein component (i)is a combination of an extract of soya beans and an extract of rapeseed.31. The method according to claim 28, wherein component (i) is selectedfrom the group consisting of 4-acetoxy-androstenedione and4-hydroxy-androstenedione.
 32. The method according to claim 28, whereinthe saw palmetto extract is an ethanol extract of saw palmetto fruits.33. The method of claim 28, wherein the method is a method for treatinga person in need thereof for reducing hair growth on the legs or facialhair on the chin and upper lip.
 34. The method of claim 28, wherein theperson in need thereof is a woman.